The Effect of Diabetes Mellitus on the Prognosis of Patients With COVID-19 (COVID-19-DM2)

May 1, 2021 updated by: Uşak University

The Effect of Diabetes Mellitus on the Morbidity and Mortality Rates in Patients With COVID-19

All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.

The patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.

The patients will be divided into two groups, as diabetics and non-diabetics. The diagnosis of diabetes mellitus will be extracted from the medical records and medical history of the patients hospitalised with COVID-19.

The COVID-19 patients medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Usak, Turkey, 64200
        • Recruiting
        • Usak University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients aged between 18-80 years, diagnosed and hospitalised for COVID-19 will be enrolled in to the study

Description

Inclusion Criteria:

  • Patients hospitalized for COVID-19

Exclusion Criteria:

  • Patients with known malignancy
  • Pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic groups
COVID-19 patients with diabetes mellitus
Other: hospitalisation, necessity of ICU, mortality rate, lung involvement
hospitalisation, necessity of ICU, mortality rate, lung involvement
Control groups
COVID-19 patients without diabetes mellitus
Other: hospitalisation, necessity of ICU, mortality rate, lung involvement
hospitalisation, necessity of ICU, mortality rate, lung involvement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Hospitalisation
Time Frame: 1 year
The time between admission to hospital and discharge
1 year
The need for ICU
Time Frame: 1 year
The admission of hospitalized patients to the intensive care unit.
1 year
Mortality
Time Frame: 1 year
Mortality rates of patients
1 year
Lung involvement
Time Frame: 1 year
The presence of lung involvement on thorax CT
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Investigators

  • Principal Investigator: Cevdet Duran, Uşak Üniversitesi Tıp fak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Actual)

October 15, 2020

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 1, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU-DM003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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